By Ludwig Burger
FRANKFURT (Reuters) -Bayer said on Friday that the European Medicines Agency recommended approval of a higher dose version of eye drug Eylea for treatment of a leading cause of blindness among the elderly, stepping up competition with Roche.
The European Commission, which has the final word on drug approvals in the EU, typically follows the recommendations issued by the EMA.
A go-ahead would mean that Eylea, an injection in the eye also known as aflibercept and jointly developed with Regeneron, can be given in doses of 8 milligrams instead of the usual 2 milligrams, allowing for longer intervals between injections.
The endorsement covers treatment of the eye diseases neovascular age-related macular degeneration and diabetic macular oedema, based on injections at intervals of up to every four months, in some cases up to five months, after three initial monthly doses.
Analysts have said the high-dose version could keep challenger Roche with its rival drug Vabysmo at bay. Vabysmo has been a major growth driver for the Swiss drugmaker since it was launched early last year.
It also requires fewer injections per year than Eylea’s established treatment course.
The U.S. Food and Drug Administration approved the higher dose version of Eylea in August, after clearance was initially held off in June.
(Reporting by Ludwig Burger; editing by Matthias Williams and Elaine Hardcastle)
